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NCT Number: NCT04003493

LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are

1. to study the nutritional status, oral health, coping, functional capacity and quality of life 2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients 3. develop an operating model to maintain good nutrition and oral health.

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Key information

Conditions

Nutrition Disorders in Old Age Caries,Dental Dental Caries Dental Deposits Dental Plaque Dentures Gingival Diseases Mouth Diseases Oral Mucositis Periodontal Diseases Plaque, Dental Stomatitis Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, FI-70210, Finland

About this study

In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • caregivers who have a caregiver´s contract valid on 1 January 2019
  • care recipients living at home

Exclusion criteria

  • in terminal care

Treatment and study plan

Nutrition and oral health intervention

Other

The interventions included individualised nutrition and oral health care.

Primary outcomes

  1. Nutritional status

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in MNA scores

  2. Albumin

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in plasma albumin concentration

  3. Prealbumin

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in plasma prealbumin concentration

  4. Body mass index (kg/m2)

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in BMI

  5. Hand grip strength

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in had grip strength of boot hands

  6. Number and location of teeth

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in number and location of teeth

  7. Type and location of removable dental prosthesis

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in type and location of removable dental prosthesis

  8. Oral mucosa

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in oral mucosa

  9. Condition of teeth

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in condition of teeth

  10. Presence of plaque

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in presence of plaque

  11. Gingival bleeding and measurement of periodontal pockets

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in gingival bleeding and measurement of periodontal pockets

  12. Dental and denture hygiene

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change dental and denture hygiene

  13. Subjective feeling of dry mouth and pain in mouth

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in subjective feeling of dry mouth and pain in mouth

Secondary outcomes

  1. Activities of Daily Living

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in Activities of Daily Living (ADL) scores

  2. Instrumental Activities of Daily Living

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in Instrumental Activities of Daily Living (IADL) scores

  3. Quality of Life (WHOQOL) -bref scores

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in quality of Life (WHOQOL) -bref scores

  4. Depression

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in Geriatric Depression Scale (GDS)-15 scores

  5. Cognition

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in Mini Mental State Examination (MMSE) scores

  6. Sense of coherence

    Time frame: Baseline and 6 months and (12 months follow-up visit)

    Change in sense of coherence (SOC) scores

  7. Morbidity

    Time frame: Baseline

    Functional Comorbidity Index (FCI) scores

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Kuopio University Hospital

Registry information

Official study title

LifE Style, Nutrition and Oral Health in Care Givers)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2019
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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